FDA 510(k) Application Details - K013396

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K013396
Device Name Neurological Stereotaxic Instrument
Applicant ALPHA OMEGA LTD.
HA'AVODA ST., P.O. BOX 810
NAZARETH ILLIT 17105 IL
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Contact AJWAD AKASHI
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 10/15/2001
Decision Date 08/07/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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